PERISPHERA-L vaginal probe for perineal electrostimulation and EMG biofeedback

The PERISPHERA-L vaginal probe is designed for pelvic floor rehabilitation using perineal electrostimulation and electromyographic (EMG) biofeedback . It incorporates two large lateral electrodes that allow stimulation of the pubococcygeus muscles and recording of muscle activity during contraction, facilitating its use in both professional treatments and home programs for urinary incontinence.

Its ergonomic, fully internal design allows for use in various positions, including sitting or standing, and may be suitable for cases of mild anterior prolapse. The electrodes are manufactured using a nickel-free galvanic technique and feature a gold contact surface, making the probe suitable for patients with nickel allergies. Weighing only 14 grams and without rigid extensions , it offers comfortable, lightweight, and discreet application .

Strengths:

- Indicated for perineal electrostimulation and EMG biofeedback

- Designed for pelvic floor rehabilitation

- Suitable for the treatment of urinary incontinence

- Two large surface lateral electrodes

- It allows stimulation and recording of the activity of the pubococcygeus muscles

- Ergonomic design for comfortable insertion

- Can be used in lying, sitting or standing positions

- Usable in the presence of mild anterior prolapse

- Electrodes with gold contact surface

- Manufactured using a nickel-free galvanic technique

- Suitable for patients with nickel allergy

- Latex-free

- Completely internal design, similar to using a tampon

- Ultralight weight of only 14 grams

- Protection of cables against tension and moisture

- For professional or home use by a single patient

- Class IIa medical device with CE marking

Technical specifications:

- Product type: vaginal probe for electrostimulation and EMG biofeedback

- Number of electrodes: 2 lateral electrodes

- Surface area of each electrode: 3.2 cm²

- Materials in contact with the patient: ABS, MABS, TPE and gold

- Coating: nickel-free galvanic technique

- Latex: latex-free

- Dimensions of the insertable body: 34 x 15 mm

- Insertable length: 66 mm

- Total length: 66 mm

- Weight: 14 g

- Color: white

- Maximum application type: up to 1 hour

- Personal use: up to 60 sessions per patient

- Presentation: non-sterile individual supply with instructions for use

- Cleaning: water and mild soap

- Disinfection: 70% hydroalcoholic solution followed by rinsing

- Sterilization: not sterilizable

- Maximum compatible current: 50 mA RMS

- Maximum compatible voltage: ±80 V, equivalent to 160 Vpp

- Maximum frequency: 200 Hz

- Maximum pulse width: 500 µs

- Connection: output cables with 2 mm termination

- Compatibility: Class IIa medical devices that deliver symmetrical biphasic impulses with a mean value of zero

- Operating and storage temperature: from +5 °C to +35 °C

- Relative humidity: between 20% and 80%

- Manufacturing certifications: ISO 9001 and ISO 13485

- CE Marking: CE0051 in accordance with European Regulation 2017/745 MDR

- CND-EMDN Code: U070399